The US Food and Drug Administration (FDA) has finalized guidance for industry on the pathway for discussions about complex products. The final guidance leaves largely untouched a 2017 draft guidance ...
The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development. “Since these products are ...
BEECH ISLAND, S.C.--(BUSINESS WIRE)--Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced today that a ...
The MarketWatch News Department was not involved in the creation of this content. Partner Apotex Corp. (Apotex) to market and distribute to the U.S. healthcare market MIRAMAR, Fla., April 9, 2026 ...
WESTON, Fla., April 10, 2026 /PRNewswire/ - Apotex Corp. today announced it has received the first U.S. Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application ...
Gottlieb is a senior fellow at the American Enterprise Institute and served as commissioner of the Food and Drug Administration from 2017 to 2019. President Trump often touted during his first term ...
MIRAMAR, Fla., March 11, 2026 /PRNewswire/ -- DifGen Pharmaceuticals LLC, a U.S.-based specialty generic pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has ...
Amphastar has received permission from the Food and Drug Administration for iron sucrose injection, 50mg/2.5ml, 100mg/5ml and 200mg/10ml in single-dose vials, previously referred to as AMP-002. Iron ...
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